The present invention relates, inter alia, to a smokeless and spitless tobacco product, a melt-spun tobacco composition, a method for manufacturing a smokeless tobacco product and a method for delivering nicotine contained in tobacco to a user. The present invention also involves a unique method of amalgamating significant amounts of tobacco with a feedstock in resulting in a dissolvable tobacco composition.
American consumption of smokeless tobacco is growing while cigarette smoking is declining. Awareness of the potential health risks of smoking, the potential risks of second hand smoke to third parties, and the increasing existence of cigarette smoking bans are all factors that are helping to shift tobacco consumption from cigarettes to smokeless tobacco. U.S. sales of moist snuff increased 10% in 2006 after several years of 6% growth while cigarette consumption declined. Another potential contributing factor to this shift is the increasingly held view in the public health community that smokeless tobacco may be much less harmful to the health of the user than is cigarette smoking. In addition smokeless tobacco does not infiltrate the air surrounding the users with tobacco smoke.
Smokers want alternatives to cigarette smoking. UST Inc., a holding company for U.S. Smokeless Tobacco Company, estimates that over half of US smokers are seeking smoking alternatives. Despite this fact, US smokers are generally reluctant to try smokeless tobacco products. Moreover, American consumers generally react poorly to traditional smokeless tobacco products when they do try such products.
Snus style smokeless tobacco is a steam cured tobacco popularized in Norway and Sweden that is either loose or contained in a pouch and is placed in the cheek. Dipping tobacco is another type of tobacco placed in the cheek. Now long cut tobacco has been put in single portion pouches in the past. Single portion pouches are considered convenient and are gaining increasing sales among smokeless tobacco users. Fine ground snuff tobacco has been known for centuries. Snuff is fine-ground tobacco intended for use by being sniffed or snorted into the nose or placed in the cheek In addition, a certain social opprobrium is associated with tobacco-induced spitting and/or the removal of tobacco from the mouth after use whether in a pouch or not.
As noted in a report by Swedish Match North Europe AB on its website at http://www.gothiatek.com/templates/start.aspx?page_id=73 entitled “Nicotine uptake from snus,” (the content, including the citations therein, of which is incorporated herein in its entirety), nicotine contained in Swedish snus, has well-documented pharmacological effects on the central nervous system. Both the dose and the uptake rate are of importance for understanding the biological effects of nicotine in humans. The amount of nicotine that is absorbed during snus use (nicotine dose) can be quantified by measuring the concentration of nicotine or its metabolites in different body fluids, i.e. blood, saliva and urine. The uptake rate can be estimated by monitoring the increase of the blood nicotine concentration over time. The nicotine uptake from Swedish snus has been described in six scientific publications of different objectives and design. As noted in that report, the nicotine uptake from one pinch of snus is determined both by the amount of nicotine that is released from the pinch during snus use and by the amount of nicotine that passes the buccal mucosa and reaches the systemic circulation; almost half of the nicotine present in the pinch was extracted during snus use (37% from portion-packed snus and 49% from loose snus). By comparison of the total amount of excreted nicotine with the total amount of nicotine in the pinch per time unit, it has been concluded that only 10-20% of the nicotine originally present in the snus pinch is absorbed via the buccal mucosa and reaches the systemic circulation. The current inventor has demonstrated a superior method to deliver nicotine from tobacco using a slow dissolving extruded sheet containing tobacco (see Fuisz U.S. Patent Application Publication No. 2009/0095313 A1, the entire content of which is hereby incorporated by reference herein and, specifically, the clinical testing taught as an example therein).
Because smokeless tobacco users look to nicotine uptake as significant component to tobacco satisfaction, and it is desirable to maximize nicotine absorption from a given amount of tobacco, allowing the user to reduce the amount of tobacco used for a given level of nicotine absorption.
A pouch due to its thickness is exposed to a significant degree of saliva flow. This flow carries a percentage of nicotine that is significant down the throat and into the stomach, with the saliva and importantly is directly related to the amount of tobacco in the material. This nicotine is subject to first pass physiology as well. In addition the pouch wall also serves as an obstruction to nicotine outflow from the tobacco. Unpouched tobacco plugs and pinches are subject to the same dynamic. The tobacco sheet taught in US 20090095313 does not suffer from such a deficit; the product of the current invention, too, traverses this hazard.
It is beneficial to have a fully dissolving, spitless smokeless tobacco product which can be enjoyed by a user without the need to remove the product after use.
Various dissolving tobacco products have been taught.
Williams U.S. Pat. No. 6,669,839, issued Dec. 30, 2003, discloses a low nitrosamine tobacco tablet comprising at least 50% tobacco.
Williams U.S. Pat. No. 6,834,654, issued Dec. 28, 2004, discloses a low nitrosamine tobacco composition formed from pulverized tobacco and consisting essentially of Virginia flue cured tobacco.
Pera U.S. Pat. No. 6,845,777, issued Jan. 25, 2005, discloses a product comprised of tobacco, an antioxidant, caffeine and S-Adenosyl-Methionine in a tablet or capsule that is allowed to disintegrate in the mouth or buccal cavity.
Strickland et al WO 2005/04363 discloses various forms including wet cast thin films containing tobacco, tabs, toothpick like rods and wet cast flakes.
Wren WO 2007/138484 discloses fast dissolving film strips containing over 50% tobacco that dissolve in less than a minute and “preferably faster.” Mua et al US 2008/0029117 A1 disclose examples of wet cast films containing tobacco, and aqueous mixtures that are extruded as films or sheets through a pasta maker. Engstrom WO 2006/004480 discloses certain dissolvable, multilayer tobacco matrixes and specific length to thickness ratios. See also Fuisz 20090095313 cited above.
The quick dissolving tobacco products that are disclosed in the above art are primarily wet cast thin film compositions that disintegrate rapidly in the mouth. It is highly doubtful that such fast dissolving products could deliver acceptable tobacco satisfaction, including sufficient nicotine absorption. They also suffer from a surface area which is so short lived that it cannot fulfill its role. Instead, the matrix will fully dissolve before acceptable nicotine is absorbed by the oral mucosa from the tobacco, and the tobacco from the dissolved matrix will be swallowed. Undoubtedly, this is part of the reason why none of these products have been sold commercially. The slower dissolving tobacco products disclosed in the art cited above (e.g. Williams) are subject to substantial salivary flow and hence are inefficient vehicles for nicotine delivery. This, together with taste and other consumer concerns has presumably led to the negligible sales in the United States of the Stonewall® and Arriva® dissolvable tobacco tablets.
In a substantial advance from the prior art, Fuisz demonstrates superior nicotine absorption through the use of a slow dissolving tobacco sheet in US 2009/0095313.
It is well understood that tobacco users are sophisticated users of nicotine, and that tobacco users may essentially titrate nicotine levels through their use of tobacco products, including cigarettes and smokeless tobacco products. Like the general populations however tobacco users also want more convenient products that better fit the modern lifestyle. Thus, sales of easy to use portion packaged smokeless tobacco are rapidly increasing at the expense of loose packaged tobacco. Dissolvable and spitless tobacco products offer a further advance with respect to convenience. However, none of the forms of dissolvable tobacco currently taught allow the user to easily manipulate the dose of tobacco used. This is taught by the current invention, which can be seen as a chewing tobacco that is also spitless and fully dissolvable. This means that the user can control dosing not merely through dosing frequency but through the size of the “pinch” of product selected by the user.
Various pharmaceutical and food compositions made using “melt-spinning” have been taught by one of the present inventors. See the following US patents and related foreign patents of Dr. Richard Fuisz, each of which is incorporated by reference as if fully stated herein: U.S. Pat. No. 4,855,326 (Rapidly dissoluble medicinal dosage unit and method of manufacture), U.S. Pat. No. 4,873,085 (Spun fibrous cosmetic and method of use), U.S. Pat. No. 4,997,856 (Method of producing compacted dispersible systems), U.S. Pat. No. 5,011,532 (Dispersed systems and method of manufacture), U.S. Pat. No. 5,028,632 (Taste masked medicated pharmaceutical), U.S. Pat. No. 5,034,421 (Moderated spun fibrous system and method of manufacture), U.S. Pat. No. 5,096,492 (Dispersed systems and method of manufacture), U.S. Pat. No. 5,196,199 (Hydrophilic form of perfluoro compounds and method of manufacture), U.S. Pat. No. 5,236,734 (Method of preparing a proteinaceous food product containing a melt spun oleaginous matrix), U.S. Pat. No. 5,238,696 (Method of preparing a frozen comestible), U.S. Pat. No. 5,268,110 (Oil removing method), U.S. Pat. No. 5,279,849 (Dispersible polydextrose, compositions containing same and method for the preparation thereof), U.S. Pat. No. 5,286,513 (Proteinaceous food product containing a melt spun oleaginous matrix), U.S. Pat. No. 5,288,508 (Delivery systems containing elastomer solvents subjected to flash flow), U.S. Pat. No. 5,348,758 (Controlled melting point matrix formed with admixtures of a shearform matrix material and an oleaginous material), U.S. Pat. No. 5,370,881 (Water-soluble delivery systems for hydrophobic liquids), U.S. Pat. No. 5,374,447 (Method of preparing a reduced-fat meat product), U.S. Pat. No. 5,380,473 (Process for making shearform matrix), U.S. Pat. No. 5,387,431 (Saccharide-based matrix), U.S. Pat. No. 5,407,676 (Hydrophilic form of perfluoro compounds and a method of manufacture), U.S. Pat. No. 5,422,136 (Starch-based food enhancing ingredient), U.S. Pat. No. 5,427,804 (Low-fat edible proteins with maltodextrins and low-saturate oils), U.S. Pat. No. 5,427,811 (Method and apparatus for spinning thermo-flow materials), U.S. Pat. No. 5,429,836 (Saccharide-based matrix), U.S. Pat. No. 5,431,950 (Reduced-fat meat product containing a melt spun oleaginous matrix), U.S. Pat. No. 5,447,423 (Apparatus for transforming the physical structure of thermo-flow material), U.S. Pat. No. 5,456,932 (Method of converting a feedstock to a shearform product and product thereof), U.S. Pat. No. 5,472,731 (Protein based food product), U.S. Pat. No. 5,490,993 (Method of preparing a proteinaceous food product containing a melt spun matrix and product thereof), U.S. Pat. No. 5,501,858 (Rapidly dispersible compositions containing polydextrose), U.S. Pat. No. 5,503,862 (Method of subjecting a protein-containing material to flash flow processing and product thereof), U.S. Pat. No. 5,516,537 (Frozen comestibles, such as frozen desserts, are formed by combining frozen comestible ingredients with a matrix resulting from melt—spinning on oleaginous substance with a carrier material), U.S. Pat. No. 5,518,551 (Spheroidal crystal sugar and method of making), U.S. Pat. No. 5,518,730 (Biodegradable controlled release flash flow melt-spun delivery system), U.S. Pat. No. 5,567,439 (Delivery of controlled-release systems(s)), U.S. Pat. No. 5,576,042 (High intensity particulate polysaccharide based liquids), U.S. Pat. No. 5,587,172 (Process for forming quickly dispersing comestible unit and product therefrom), U.S. Pat. No. 5,593,502 (Method of making crystalline sugar and products resulting therefrom), U.S. Pat. No. 5,597,416 (Method of making crystalline sugar and products resulting therefrom), U.S. Pat. No. 5,597,608 (Saccharide-based matrix incorporating maltodextrin and process for making), U.S. Pat. No. 5,601,076 (Spheroidal crystal sugar and method of making), U.S. Pat. No. 5,622,717 (Ulcer prevention method using a melt-spun hydrogel), U.S. Pat. No. 5,622,719 (Process and apparatus for making rapidly dissolving dosage units and product therefrom), U.S. Pat. No. 5,624,684 (Enzyme systems), U.S. Pat. No. 5,651,987 (Ulcer prevention and treatment composition), U.S. Pat. No. 5,654,003 (Process and apparatus for making tablets and tablets made therefrom), U.S. Pat. No. 5,709,876 (Saccharide-based matrix), U.S. Pat. No. 5,728,397 (Polydextrose product and process), U.S. Pat. No. 5,733,577 (Delivery of controlled-release system), U.S. Pat. No. 5,811,123 (Method of treating mucosal tissue), U.S. Pat. No. 5,827,563 (Spheroidal crystal sugar), U.S. Pat. No. 5,851,552 (Delivery of controlled-release system), U.S. Pat. No. 5,851,553 (Process and apparatus for making rapidly dissolving dosage units and product therefrom), U.S. Pat. No. 5,853,762 (Delivery of controlled-release system), U.S. Pat. No. 5,866,163 (Process and apparatus for making rapidly dissolving dosage units and product therefrom), U.S. Pat. No. 5,866,188 (Comestible composition having spheroidal crystal sugar), U.S. Pat. No. 5,871,781 (Apparatus for making rapidly-dissolving dosage units), U.S. Pat. No. 5,874,110 (Entrapping additives in carbohydrate bodies), U.S. Pat. No. 5,895,664 (Process for forming quickly dispersing comestible unit and product therefrom), U.S. Pat. No. 5,935,600 (Process for forming chewable quickly dispersing comestible unit and product therefrom), U.S. Pat. No. 5,965,162 (Process for forming chewable quickly dispersing multi-vitamin preparation and product therefrom), U.S. Pat. No. 5,965,164 (Recipient-dosage delivery system), U.S. Pat. No. 6,020,002 (Delivery of controlled-release system(s)), U.S. Pat. No. 6,083,430 (Method of preparing a dosage unit by direct tableting and product therefrom), U.S. Pat. No. 6,129,926 (Flash flow processing of thermoplastic polymers and products made therefrom), U.S. Pat. No. 6,171,607 (Process and apparatus for producing shearform matrix material), U.S. Pat. No. 6,277,406 (Easily processed tablet compositions), and U.S. Pat. No. 6,337,082 (Saccharide-based matrix).
None of the preceding or any other “melt-spinning” patents teach or otherwise suggest the use of a “melt-spinning” process to make smokeless tobacco compositions.
Thus, applicant has found that it is desirable to provide for a tobacco composition made by “melt-spinning.”